Trial Outcomes & Findings for A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111) (NCT NCT02409355)
NCT ID: NCT02409355
Last Updated: 2019-02-15
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
8 participants
Primary outcome timeframe
Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Atezolizumab
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
|
Gemcitabine + Cisplatin/Carboplatin
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Atezolizumab
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
|
Gemcitabine + Cisplatin/Carboplatin
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Study terminated by Sponsor
|
2
|
3
|
Baseline Characteristics
A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)
Baseline characteristics by cohort
| Measure |
Atezolizumab
n=4 Participants
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
|
Gemcitabine + Cisplatin/Carboplatin
n=4 Participants
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)Population: The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study. The planned outcome measures of this study are no longer applicable. The outcome measures were removed in the last protocol version.
Outcome measures
Outcome data not reported
Adverse Events
Atezolizumab
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Gemcitabine + Cisplatin/Carboplatin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Atezolizumab
n=4 participants at risk
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
|
Gemcitabine + Cisplatin/Carboplatin
n=4 participants at risk
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
|
|---|---|---|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Nervous system disorders
PARAPLEGIA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
Other adverse events
| Measure |
Atezolizumab
n=4 participants at risk
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
|
Gemcitabine + Cisplatin/Carboplatin
n=4 participants at risk
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
75.0%
3/4 • Number of events 3 • Baseline up to 19 months
Safety Populiation
|
|
Blood and lymphatic system disorders
GRANULOCYTOPENIA
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Gastrointestinal disorders
DIARRHOEA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Gastrointestinal disorders
NAUSEA
|
25.0%
1/4 • Number of events 2 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 2 • Baseline up to 19 months
Safety Populiation
|
|
Gastrointestinal disorders
STOMATITIS
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
General disorders
ASTHENIA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
General disorders
GENERALISED OEDEMA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
General disorders
OEDEMA PERIPHERAL
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
General disorders
PAIN
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 2 • Baseline up to 19 months
Safety Populiation
|
|
General disorders
PYREXIA
|
50.0%
2/4 • Number of events 2 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Infections and infestations
CANDIDA INFECTION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Infections and infestations
CATHETER SITE INFECTION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Infections and infestations
ORAL CANDIDIASIS
|
25.0%
1/4 • Number of events 2 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Infections and infestations
URINARY TRACT INFECTION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Injury, poisoning and procedural complications
FALL
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Investigations
WEIGHT DECREASED
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
50.0%
2/4 • Number of events 2 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
50.0%
2/4 • Number of events 2 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Metabolism and nutrition disorders
HYPOPHAGIA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
25.0%
1/4 • Number of events 2 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Nervous system disorders
ATAXIA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Nervous system disorders
DYSMETRIA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Nervous system disorders
LETHARGY
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Product Issues
THROMBOSIS IN DEVICE
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Psychiatric disorders
ANXIETY
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Psychiatric disorders
DELIRIUM
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Psychiatric disorders
DEPRESSION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Renal and urinary disorders
GLOMERULONEPHRITIS MEMBRANOUS
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Renal and urinary disorders
KIDNEY FIBROSIS
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Renal and urinary disorders
PROTEINURIA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Renal and urinary disorders
RENAL TUBULAR ATROPHY
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
50.0%
2/4 • Number of events 2 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
50.0%
2/4 • Number of events 2 • Baseline up to 19 months
Safety Populiation
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
|
Vascular disorders
HYPERTENSION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
|
Vascular disorders
HYPOTENSION
|
25.0%
1/4 • Number of events 1 • Baseline up to 19 months
Safety Populiation
|
0.00%
0/4 • Baseline up to 19 months
Safety Populiation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER